Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer

NCT ID: NCT06684652

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-09-30

Brief Summary

The goal of this randomized controlled trial (RCT) is to evaluate the efficacy and safety of different prostate biopsy schemes, including targeted biopsy plus sextant biopsy (3TB+6SB) and combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB).

The main questions it aims to answer are:

Does 3TB+6SB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of 3TB+6SB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of 3TB+6SB and combination of 3TB+12SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life.

Participants will:

Receive 3TB+6SB or 3TB+12SB.

Detailed Description

Currently, combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB) has been recommended for the diagnosis of patients with suspicious lesion found on multiparametric magnetic resonance imaging (mpMRI). Although the 3TB+12SB approach could effectively detect clinically significant prostate cancer (csPCa), the increased number of biopsy cores would increase the risk of complications and decrease the postoperative quality of life. In recent years, urological and radiologic thinking has changed after realizing that systemic biopsies may be reduced when the chance of missing a clinically significant lesion is low. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Some retrospective studies have proved that the cancer detection rate of targeted biopsy plus sextant biopsy (3TB+6SB) was not inferior to 3TB+12SB. However, the safety profile warrants further evaluation, and there is still a lack of high-quality, prospective evidence for the 3TB+6SB schemes. Thus, this randomized controlled trial (RCT) aims to evaluate the efficacy and safety of 3TB+6SB schemes and the routine 3TB+12SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.

The main questions it aims to answer are:

Does 3TB+6SB promote the accurate diagnosis of clinically significant prostate cancer? What is the value of 3TB+6SB in improving the safety of prostate biopsy? This prospective RCT compared the csPCa detection rates of 3TB+6SB and 3TB+12SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from September 2024 to February 2025. Participants were randomly allocated to 3TB+6SB group and 3TB+12SB group.

Researchers will compare the cancer detection rates of 3TB+6SB and 3TB+12SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

3TB+6SB group

For each predefined mpMRI suspicious lesion, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained sextant six-core SB.

Group Type: EXPERIMENTAL

3TB+6SB

Intervention Type: PROCEDURE

The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. For each predefined mpMRI suspicious lesion, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained sextant six-core SB. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme. Histology was evaluated by senior uropathologists who were blinded to the imaging findings.

3TB+12SB group

For patients in the 3TB+12SB group, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained fore-zone 12-core SB.

Group Type: EXPERIMENTAL

3TB+12SB

Intervention Type: PROCEDURE

The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. Urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained fore-zone 12-core SB. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme. Histology was evaluated by senior uropathologists who were blinded to the imaging findings.

Interventions

3TB+6SB

The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. For each predefined mpMRI suspicious lesion, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained sextant six-core SB. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme. Histology was evaluated by senior uropathologists who were blinded to the imaging findings.

Intervention Type: PROCEDURE

3TB+12SB

The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. Urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained fore-zone 12-core SB. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme. Histology was evaluated by senior uropathologists who were blinded to the imaging findings.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The age of the patient is between 45 and 85 years.
• No previous biopsy.
• Patients with single suspicious lesion, complete multiparametric magnetic resonance imaging (mpMRI) data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 3.
• Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) >10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) <0.16 or PSA density (PSAD) >0.15.
• The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate mpMRI examination should not exceed one month.
• Patients with complete clinical information.

Exclusion Criteria

• The mpMRI data was unqualified or incomplete.
• Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
• Patients with previous biopsy.
• Patients with PI-RADS V2.1 of < 3.
• Patients were not in accordance with the indication of prostate biopsy.
• The patient could not cooperate to complete the prostate biopsy.
• The patients or their family members refused to participate in this study.
• Patients with incomplete clinical information.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

LIU Yi

Associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi Liu

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Liu

Role: CONTACT

liuyipkuhsc@163.com

+86 13611035261

Facility Contacts

Yi Liu

Role: primary

liuyipkuhsc@163.com

+86 13611035261

Ruiyi Deng

Role: backup

1910301104@pku.edu.cn

+86 13307720043

Other Identifiers

TB+6SB_01

Identifier Type: -

Identifier Source: org_study_id